Clinical Trial PDS Attributes

You can use the attributes to describe the details of a clinical trial application for the European Union.

Attribute Description
Application Code Code of the Application to which the PDS is associated.
Application Name Name of the Application to which the PDS is associated.
Comments Any additional information that you want to save with the Shelf Life/Storage Conditions detail.
Date QC'd The date the QC Status was set.
Description Description of the Shelf Life/Storage Conditions detail.
Family Code Product Family to which the PDS is associated.
Family Name Product Family to which the PDS is associated.
Keywords Keywords that you can use in a search for the detail.

Product Detail Set

Name

PDS to which this detail is associated in the following concatenation delimited by space PDS Name + PDS Code.
Product Name Full concatenated product name to which the PDS/Template is associated (Product Name + Product Strength + Product Dosage Form +Product Code).

Product of Human or

Animal Origin

Origin of product: Animal or Human
QC Status QC Status of the detail
QC'd by Person logged on to the system who set the QC Status for the detail to QC Passed or QC Failed.
Status The status of the detail at the time of the associated event.
Status Date The date that the detail had the status.